OpenClinica CEO Cal Collins Champions HL7 FHIR

Collins leads Internal Sponsor Systems focus area of Vulcan Interoperability Bridge

NEEDHAM, MA, UNITED STATES, January 7, 2025 /EINPresswire.com/ -- OpenClinica will participate in the Vulcan Interoperability Bridge (VIB), a virtual event on February 5, 2025 organized in coordination with the US Assistant Secretary for Technology Policy/Office of the National Coordinator (ASTP/ONC), the Food and Drug Administration (FDA), and Vulcan HL7.

The event brings together the clinical research community and government to demonstrate the future of clinical research infrastructure and aims to accelerate the adoption of healthcare data standards for research. Among the key components of the VIB event are demonstrations in focus areas that represent improved end-to-end data flows in the clinical research space and how the use of HL7 FHIR^® can improve data quality, efficiency and overall cost to conduct research.

“Healthcare is now a FHIR-based world. There are significant benefits for life science organizations to adopt and build on FHIR standards to accelerate research,” said Cal Collins, OpenClinica Co-Founder and CEO. “Collaboration of multiple sponsors, sites, and technology vendors around this open standard will help improve research quality while reducing the traditional burdens faced by research staff.”

The Vulcan Interoperability Bridge features five focus areas:

-Patient
-Health Information Exchange (HIE)
-Researcher to Sponsor, featuring the OpenClinica EHR-to-EDC solution, Unite
-Regulatory AE Investigations
-Internal Sponsor Systems, which is led by OpenClinica’s Cal Collins.

As part of the showcase, OpenClinica will demonstrate sharing of digital protocol definitions within sponsor systems and from sponsor to healthcare sites using FHIR’s Schedule of Activities (SoA), and will show electronic submission of Adverse Event reports to the FDA using the FHIR AE guide, based on data acquired from a patient’s Electronic Health Record. These advancements are made possible through OpenClinica’s collaboration with the FDA, Quantum Leap Healthcare Collaborative, the University of California, San Francisco, and ESPERO. This collaboration highlights the collective commitment to leveraging FHIR standards to transform clinical research and patient care.

“Interoperability delivers significant advantages, including better data quality and more efficient data collection. It also streamlines study planning, startup, and execution while aligning clinical care with research to benefit patients and reduce site burden," stated Collins. "This is why OpenClinica has joined over 40 organizations in the HL7 Vulcan FHIR Accelerator and is proud to co-lead the Vulcan Interoperability Bridge event.”

To learn more and register to participate in the Vulcan Interoperability Bridge event, visit: Here

To learn more about EHR-to-EDC integration for clinical research, read this article.

ABOUT OPENCLINICA
OpenClinica accelerates clinical trials by automating data acquisition through its software-as-a-service platform. Offering a secure bridge between healthcare and research, OpenClinica is trusted by the world’s foremost life science companies, academic institutions, and government entities and has been used in more than 10,000 studies involving over five million patients. OpenClinica is proud to support hundreds of small, midsize and large research organizations spanning biotech, pharma, medical device manufacturing and contract research organizations. For more information, visit us at www.openclinica.com.

ABOUT HL7
Health Level Seven International (HL7) Health Level Seven^® International (HL7) is an ANSI-accredited, not-for-profit standards developing organization with the mission of empowering global health interoperability. With affiliates in over 30 countries, HL7’s global membership envisions a world in which everyone can securely access and use the right data when and where they need it. Widely implemented by vendor and health care systems, and required by governing bodies around the world, HL7 standards deliver solutions for health information technology, including HL7^® Fast Healthcare Interoperability Resources (FHIR^®), Version 2 (V2) and Clinical Document Architecture (CDA^®). For more information, visit HL7.org. www.HL7.org.

ABOUT Vulcan
An HL7^® FHIR^® Accelerator, Vulcan’s mission is to accelerate interoperability of health data to seamlessly integrate clinical and translational research with clinical care in order to reduce burden, enable learning health systems, and improve patients’ lives. Vulcan is a diverse research community that creates FHIR^® implementation guides for the exchange of health and research data, creating alignment at the development of standards through to implementation. HL7 Vulcan Accelerator is currently accepting new members. To learn more about participating in Vulcan, please contact vulcan@hl7.org or visit https://hl7vulcan.org/.

Mary Lou McCoy
OpenClinica
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